Kornimate/medical-research-clean huggingface dataset:
effects of changes in fluid status on right ventricular volumes and function

Conditions: Tetralogy of Fallot

Summary: the purpose of this study is to evaluate the correlation between fluid volume status and right ventricular volume and function, in those with free pulmonary valve insufficiency after tetralogy of fallot (tof) repair.

the purpose of this study is to measure the changes in right ventricular size and function with changes in preload, using cardiovascular magnetic resonance (cmr). based on an intensive research and clinical observations the investigators hypothesize that changes in volume status cause a statistically significant difference in the cardiovascular magnetic resonance (cmr) measured rv end diastolic volume (edv), end-systolic volume (esv), ejection fraction (ef) and pulmonary regurgitation (pr). the investigator hypothesizes that smaller changes will occur in left ventricular lv edv, esv, and ef. 1. to establish a correlation between the changes in preload volume status and rv size and function in patients with free pulmonary insufficiency (pi) after tof repair using cmri. 2. to assess the effects of preload status on the measured severity of pulmonary regurgitation (pr). 3. to assess the effects of preload status on the left ventricular (lv) size this study will be conducted in compliance with this protocol, good clinical practice and the applicable regulatory requirements.

Eligibility criteria:
inclusion criteria: 1. tof patients who have had repair using a transannular patch. 2. patients that present with free pulmonary insufficiency. 3. are older than 18 years. exclusion criteria: 1. patients who have lesions predisposing to chronic volume overload (i.e. patients with significant residual postoperative ventricular septal defects (vsd), or large aorto-pulmonary collaterals or more than moderate tricuspid insufficiency) since all these hemodynamic conditions can influence the late function of the right ventricle and potentially affect the response of the right side of the heart in changes in volume status 2. patients who had a valve sparing tof repair and have less than free pulmonary insufficiency. 3. patients who have significant residual right-sided obstruction (i.e. patients who have residual rvot obstruction or significant residual branch pulmonary artery stenosis), as it is shown that residual pulmonary stenosis may protect from rv dilation and from deterioration of the rv function. 4. patients who cannot be reconstructed with a transannular patch and/or require a right ventricle to pulmonary artery homograft for reconstruction including: * pulmonary atresia and vsd * patients with anomalous coronary crossing the right ventricular outflow tract (rvot) and * patients with tof-absent pulmonary valve syndrome. 5. patients with renal failure and renal insufficiency 6. patients with uncompensated heart failure 7. cancer patients 8. latex allergic patients 9. patients with diabetes 10. pregnant females 11. prisoners 12. individuals who lack consent capacity
clinical evaluation of intraocular caliper-assisted capsulotomy for age-related cataract

Conditions: Cataract Extraction

Summary: the purpose of this study is to compare the accuracy of capsulotomy assisted by intraocular caliper and verion navigation system in phacoemulsification surgery and postoperative visual quality of patients.

continuous curvilinear capsulorhexis (ccc) is an important and technically challenging procedure in cataract surgery. however, most surgeons perform ccc by experience or referring to the pupil size, which is highly subjective and the accuracy of capsulorhexis is unsatisfactory. the investigators developed a new modified intraocular caliper with standard calibration on the rinse needle, which can measure and locate the position of capsulorhexis. the surgeon can gently use the blunt needle in the front of the intraocular caliper to further make corresponding markers on the lens anterior capsule, and then carry out capsulotomy according to the marks. we found intraocular caliper-assisted capsulotomy can obviously improve the accuracy of capsulorhexis. the purpose of this study is to compare the accuracy and postoperative visual quality of intraocular caliper-assisted capsulotomy with those of digital image projection device verion navigation system.

Eligibility criteria:
inclusion criteria: * adults aged 55 to 80 years with age-related cataract; * pupil diameter ≥ 6.5mm after pupil dilation; * lens nuclear opacity grading score (locs iii) lower than 4.0. exclusion criteria: * patients had previous intraocular surgery; * patients with a diagnosed eye disease that may affect the functions of lens suspensory ligament such as previous ocular trauma, lens subluxation, pseudoexfoliation syndrome, retinal pigment degeneration; * patients had other ocular diseases that impair visual function include optic neuropathy, uveitis, and tumor. * refused to participate the study.
symptomatic relief of action tremor with cala trio using trio+ bands

Conditions: Essential Tremor; Parkinson Disease

Summary: demonstrate safety and effectiveness of symptomatic action tremor relief in the treated hand following stimulation with the cala trio system using the trio+ bands as compared to the trio bands in adults with essential tremor (et) and/or parkinson's disease (pd) over 2 weeks.

20 patients with (13 with et and 7 with pd) with at least mild postural tremor were enrolled in a prospective, single-center, two-arm, crossover study that took place over the course of four weeks. taps devices were shipped to patients to run the study remotely. in the first arm of the study, subjects received taps treatment using the original. cala trio band for two weeks. followed by a wash-out period (\> 24 hours), subjects entered the second arm and received taps using the trio+ band for an additional two weeks. unsupervised motion assessments were captured at home, and at the beginning and end of the four weeks by telemedicine.

Eligibility criteria:
inclusion criteria: * must be ≥22 years of age * competent and willing to provide written, informed consent to participate in the study * willing to comply with study protocol requirements for subjects with essential tremor: * a diagnosis of essential tremor * a tremor severity score of 2 or above in the dominant hand/arm as measured by one of the tetras upper limb postural tremor items * no significant alcohol intake within 8 hours prior to study visits for subjects with parkinson's disease: * dominant hand/arm exhibiting postural tremor ≥ 2 (while in the off state) as assessed by the mds-updrs postural tremor score * stable dose of parkinson's disease medications, if applicable, for 30 days prior to study entry exclusion criteria: * implanted electrical medical device, such as a pacemaker, defibrillator, or deep brain stimulator * suspected or diagnosed epilepsy or other seizure disorder * any skin condition at the stimulation site that in the investigator's opinion should preclude participation in this study * diagnosed with peripheral neuropathy affecting the tested upper extremity * presence of any other neurodegenerative disease other than essential tremor or parkinson's disease * subjects unable to communicate with the investigator and staff * any health condition or concomitant medication that in the investigator's opinion should preclude participation in this study * pregnancy or anticipated pregnancy during the course of the study * botulinum toxin injection for hand tremor within 6 months prior to study enrollment * are participating or have participated in another interventional clinical trial in the last 30 days which may confound the results of this study, unless approved by the sponsor
evaluation of pemetrexed combined with cisplatin and radiotherapy for unresectable locally advanced non-small cell lung cancer (nsclc)

Conditions: Non-Small Cell Lung Cancer

Summary: the aim of this study is to evaluate if the multi modality treatment pemetrexed combined with cisplatin and radiotherapy can lead to a better tumor control and/or a better side-effect profile in patients with locally advanced nsclc. patients will be randomized between 3 cycles of induction chemotherapy followed by concurrent chemoradiotherapy or concurrent chemoradiotherapy followed by 3 cycles of adjuvant combination chemotherapy.


Eligibility criteria:
inclusion criteria: * cytological or histological proven nsclc * unresectable stage iii nsclc * presence of at least one measurable lesion (recist criteria) * adequate haematological, renal and hepatic function * adequate lung function reserve * good condition, weight loss \ 3 months exclusion criteria: * previous chemo- or radiotherapy for nsclc * distant metastasis or a malignant pleural or pericardial effusion * second active primary malignancy or serious concomitant medical disease * interstitial lung disease * auto-immune systemic disease with potential involvement of the lungs * inability to interrupt aspirin or other non-steroidal anti-inflammatory agents for a 5-day period * concomitant use of amiodarone

Keywords: non-small cell lung cancer nsclc chemoradiation locally advanced nsclc pemetrexed lung cancer
custom-dbs: current steering to optimize deep brain stimulation

Conditions: Parkinson's Disease

Summary: the objective of the study is to compare different deep brain stimulation (dbs) settings using the commercially approved boston scientific neuromodulation vercise system.

the study is a prospective, multi-center, double-blind, randomized controlled trial. this study will compare various program settings for the bilateral stimulation of the stn using the bsc implantable vercise™ dbs system for the treatment of levodopa-responsive, moderate to severe idiopathic pd.

Eligibility criteria:
inclusion criteria: * implanted bilaterally in stn with a vercise dbs system for parkinson's disease for at least three months with programming optimized according to standard of care. * updrs subset iii score of ≥30 in the in the pre-operative meds off state. * dbs must improve pd symptoms by ≥30% in the meds off state, as measured by updrs subset iii score. * medical and mental fitness to comply with programming visit and study related procedures. * able to understand the study requirements and the treatment procedures and provides written informed consent before any study-specific tests or procedures are performed. * off symptom rigidity score of ≥2 in the evaluated arm as determined by the updrs-iii. exclusion criteria: * have any significant medical condition that is likely to interfere with study procedures or likely to confound evaluation of study endpoints, including any terminal illness with survival \<12 months. * resting and/or action tremor score of ≥3 on the evaluated side as determined by the updrs-iii in pre-operative meds off condition.

Keywords: stimulation, implantable pulse generator, deep brain stimulation
a survey of management of analgesia, sedation and delirium in icu patients in china

Conditions: Delirium on Emergence; Analgesia; Separation

Summary: in 2018, the severe medicine branch of the chinese medical association and the american society of severe medicine successively updated the pain and sedation guidelines for severe patients (padis guidelines). in addition to the update of the original evaluation and management of pain and sedation and delirium, the new guidelines also increased the monitoring and management of early activities and sleep quality for severe patients. therefore, it is necessary for us to investigate the compliance of the new guidelines for analgesia, sedation and delirium management among the medical staff of critical care, so as to find out the existing problems in the management of analgesia, sedation and delirium in critical care patients, and find solutions to improve the overall quality level of our management of critical care patients

the first part is to master the current situation of analgesia, sedation and delirium management of icu patients in china. in order to understand the compliance of chinese icu doctors and nurses with the padis guidelines, a questionnaire survey was conducted with the participation of multiple centers in china, aiming at the doctors and nurses with different seniority in the critical medicine department. at the same time, the total number of critically ill patients, pain, agitation and delirium assessment tools and critical patients in 2018 were investigated the incidence of pain, agitation and delirium, the implementation of early activities, the monitoring and evaluation of sleep quality, and related interventions, including real-world clinical data such as drug treatment and non drug treatment.the second part focuses on the management of severe delirium in icu in china. for the patients with delirium in the above survey, a further in-depth and detailed survey shall be conducted, covering the basic diseases of the patients, the occurrence time of delirium, the type of delirium, relevant risk factors, the diagnosis method of delirium, the duration of delirium, the prevention and treatment measures (including drug treatment and non drug treatment measures), and the prognosis of delirium patients .

Eligibility criteria:
inclusion criteria: * age ≥ 18 years old; * stay in icu for more than 24 hours and have used analgesics and sedatives. exclusion criteria: * before entering the icu, they had mental illness and dementia; * coma or deep sedation could not be evaluated; * brain injury, stroke sequelae, epilepsy and other brain diseases; * nerious audio-visual dysfunction and unable to communicate normally. * pregnant and lactating women

Keywords: analgesia sedation icu delirium
treatment of bronchiolitis with heated humidified high flow nasal cannula - prospective and retrospective research

Conditions: Bronchiolitis

Summary: bronchiolitis is an acute lower airway infection caused by a viral infection. it is a major cause of winter admissions to pediatric wards. accepted therapies include oxygen support and iv fluids, whereas other supportive therapies such as inhalations are of questionable benefit. moderate to severe cases are a source of distress to patient, parents and medical staff often necessitating pediatric intensive care unit admission. heated humidified high flow nasal cannula (hhhfnc) therapy has been shown lately to improve the work of breathing, oxygen saturation, and co2 pressure (pco2) values as well as decrease picu admissions and intubation rates. we planned a prospective and retrospective study in order to check the feasibility of using hhhfnc in a primary pediatric ward and its effect on clinical well being, respiratory status and picu admission.

supportive care, single group assignment, open label, non-randomized, efficacy study the research is devised as follows: prospective section: we will enroll children 0-2 years old, diagnosed with bronchiolitis in our ward (pediatrics c) during the months of november-march 2014-2016. children will be evaluated according to a bronchiolitis severity score devised by wang and co which was successfully used in previous research. children answering criteria for moderate or severe bronchiolitis according to wang and co. will be enrolled pending written consent by both parents. our prediction is to enroll a total of 200 children during the 2 winter seasons during 2014-2016. retrospective section: we will examine up to 200 cases of children aged 0-2 years hospitalized due to bronchiolitis in pediatrics c during 2014-2016 which were not enrolled in our research (due to lack of consent/unavailable hhhfnc etc.). we will compare clinical data and vital parameters between the groups treated with hhhfnc and those who were not.

Eligibility criteria:
inclusion criteria: in age interval, diagnosed with bronchiolitis exclusion criteria: chronic heart/lung disease, immunocompromised state
novel diagnosis of ectopic pregnancy

Conditions: Ectopic Pregnancy; hCG; Pregnancy of Unknown Location

Summary: in the project, the investigators aim to determine the beta- human chorionic gonadotropin (bhcg) value with serial measurements on the same day in the diagnosis of ectopic pregnancy.

ectopic pregnancy is when the conception material is in a location other than the endometrial cavity. the diagnosis of ectopic pregnancy is basically made by the lack of increase in serum bhcg values as in normal pregnancy. in normal pregnancies, bhcg value increases by 70% or more every 2 days. in ectopic pregnancy, an increase of less than 70% every 2 days is diagnostic. this classical method allows the diagnosis to be made within 2-4 days at the earliest. most of the time, this period can take 6-10 days. in the project, the investigators will investigate how to determine the bhcg value with serial measurements on the same day in the diagnosis of ectopic pregnancy. the fact that there is no 70% increase after 2 days in ectopic pregnancy suggests that there may be an irregular increase during the day. the investigators aim to make this diagnosis in a shorter time than long days by measuring bhcg values many times during the day in patients with suspected ectopic pregnancy. the fact that there is no other study on this subject in the literature strengthens the possibility of the project being published as valuable information for the literature, even if a negative result is obtained as a result of this study.

Eligibility criteria:
inclusion criteria: * positive bhcg levels exclusion criteria: * clinically diagnosis of intrauterine pregnancy

Keywords: ectopic pregnancy hcg pregnancy with unknown location
early breast growth in girls aged 6 to 8 years in the current environmental context

Conditions: Puberty, Precocious; Breast; Environmental Exposure

Summary: various studies show an increase in the number of cases of early puberty in girls with breast development with a variable clinical presentation and evolution. this increasing phenomenon concerns girls between 6 and 8 years old. in a large number of cases, from 70 to 95% depending on the series, no medical cause is found and environmental factors are suspected to be involved. descriptive studies of these patients are scarce and not always provide an overview of all the parameters in line with the concept of the exposome. the penelope clinical trial will allow to analyze a large number of parameters, including the adipose tissue, its metabolism, the endocrine disruptors, and the epigenetic modifications, and to study the impact of environmental health measures in the evolution of these parameters. the data from the analyses of the endocrine disruptors of the patients will be explored in parallel in experimental models (amphibians, murine, cellular) in order to test potential mechanistic hypotheses.


Eligibility criteria:
inclusion criteria: * girls aged 6 to 8 years * presenting a breast development (isolated or not) * undergoing scheduled pediatric day hospital care (hdj) * who agree to participate in the study * whose parents agree to their child's participation in the study * french speaking * whose parents speak french * affiliated to social security exclusion criteria: * organic brain causes of precocious puberty: history of neurocerebral disease (malformations, developmental abnormalities) * organic causes of precocious puberty: mac cune albright syndrome, ovarian cyst or tumor and adrenal hyperplasia * history of chemotherapy or radiation therapy * presenting with a communication disorder * pregnancy * persons under protective measures * persons deprived of liberty for judicial or administrative reasons

Keywords: early puberty endocrine disruptors girls breast growth environmental health measure
promoting caregiver implementation of an effective early learning intervention

Conditions: Developmental Language Disorder; Reading; Difficult

Summary: the goal of this study is to examine the impact of a caregiver-implemented shared reading program, sit together and read (star), on children ages 4 to 5 with developmental language disorder. the main questions it aims to answer are: * how much star impacts children's literacy skills in the short-term and long-term--up to two-years after completing star. * how do caregiver supports in the form of small monetary rewards or encouraging texts help caregivers to implement star at its intended frequency of sessions per week. caregiver participants will be assigned to either a control group or one of three star groups. children's skills related to literacy and learning will be assessed before the intervention starts, at the end of the intervention, and every six months post-intervention for two years. researchers will determine the short term and long term impacts of star compared to the control group. researchers will compare the three star conditions to see if the rewards or encouragement helped parents to follow through with completing more star sessions.


Eligibility criteria:
inclusion criteria: * receiving or on waitlist for speech services * primary complaint of impaired language skills * receptive, expressive, or mixed language disorder * primarily communicates in english exclusion criteria: 1. no known additional diagnoses causal of developmental language disorder including 1. autism spectrum disorder 2. hearing loss 3. severe intellectual disability 2. is not attending or has completed kindergarten

Keywords: randomized control trial print knowledge reading outcomes literacy behavior-change strategies early literacy
effects of occupational therapy in copd

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease is a chronic condition involving an impairment in functionality and in the execution of activities of daily life. the hypothesis of this study is that an occupational therapy intervention added to a physiotherapy program and a medical treatment increase the functionality and the quality of life of patients with chronic obstructive pulmonary disease.

the evolution of chronic obstructive pulmonary disease can be aggravated in some periods by an increase of the symptoms (above all, the cough, the dyspnea and the quantity of sputum purulence). this is known as exacerbation, and it is the most frequent reason for hospital stay, urgences services and death in this condition. a physiotherapy program and an occupational therapy intervention are carrying out in patients attending to the hospital because of an exacerbation.. participants will be assessed at baseline and again at the end of the study.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of chronic obstructive pulmonary disease with exacerbation. * no contraindication of physiotherapy. * signed written consent. * medical approval for inclusion exclusion criteria: * heart disease. * neurological patients. * contraindications of physiotherapy. * nursing home residents. * cognitive impairments.

Keywords: exacerbation functionality occupational therapy chronic obstructive pulmonary disease